THALIDOMIDE | N020785 | BRISTOL-MYERS SQUIBB CO
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
CELGENE CORPORATION v. HIKMA PHARMACEUTICALS INTERNATIONAL LIMITED et al 9 patentsANDA 211947thalidomide | D.N.J. | 2018-08-31 | Terminated 2019-09-18 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Celgene Corporation - Citizen Petition FDA-2007-P-0113 Celgene Corporation filed this citizen petition on September 20, 2007, requesting that the FDA refrain from approving Barr Laboratories' ANDA 78-505 for a generic thalidomide product for treating erythema nodosum leprosum, citing unacceptable safety risks and violation of Celgene's orphan drug exclu | 505(q) | 2008-04-28 | Denied | — |
State of Connecticut FDA-2005-P-0004 Researchers from the National Cancer Institute conducted a randomized phase II trial of docetaxel (Taxotere) combined with thalidomide in patients with androgen-independent prostate cancer, based on their individual single-agent activity and evidence of complementary mechanisms of action. The study | Other | 2005-05-04 | Granted | — |
State of Connecticut FDA-2005-P-0004 Richard Blumenthal, Connecticut's Attorney General, filed this citizen petition requesting that the FDA strengthen Thalomid's labeling and implement additional safety measures for Celgene Corporation's thalidomide product. The petitioner contends that although Thalomid is approved only for treating | Other | 2005-05-04 | Granted | — |
State of Connecticut FDA-2005-P-0004 This document is not an FDA citizen petition. It is a feature article by Dr. V Pannikar of the WHO's Communicable Diseases (Leprosy Group) discussing the history of thalidomide, its use in treating erythema nodosum leprosum in leprosy patients, and concerns about its reintroduction for other indicat | Other | 2005-05-04 | Granted | — |
State of Connecticut FDA-2005-P-0004 The provided document is an information brochure for Thalidomide Pharmion 50 mg Hard Capsules approved in Australia, not a citizen petition to the FDA. It contains clinical and safety information about thalidomide for treating multiple myeloma and erythema nodosum leprosum, including details on mech | Other | 2005-05-04 | Granted | — |
State of Connecticut FDA-2005-P-0004 The State of Connecticut, through researchers affiliated with Northwestern University and the VA Healthcare System, filed this petition analyzing pharmacovigilance data on thalidomide-associated thromboembolism in cancer patients receiving off-label treatment. The petition requested improvements in | Other | 2005-05-04 | Granted | — |
State of Connecticut FDA-2005-P-0004 The State of Connecticut did not file this FDA citizen petition. This document is a transcript of a presentation by Celgene Corporation executives at a JMP Securities research conference on March 2, 2005, discussing the company's marketed products including Thalomid and its pipeline candidate Revlim | Other | 2005-05-04 | Granted | — |
State of Connecticut FDA-2005-P-0004 This document is a PBS NewsHour transcript from August 1998 about thalidomide's FDA approval for treating leprosy, not an FDA citizen petition. It contains no petition filing, no specific drug approval request mechanism such as NDA or ANDA, and no formal regulatory action being requested by any peti | Other | 2005-05-04 | Granted | — |
State of Connecticut FDA-2005-P-0004 This document is not a citizen petition to the FDA; it is a corporate brochure or annual report from Celgene Corporation describing its cancer drug pipeline and business achievements as of 2003. The document presents information about Celgene's marketed product THALOMID (thalidomide) and investigati | Other | 2005-05-04 | Granted | — |
State of Connecticut FDA-2005-P-0004 This document does not appear to be an FDA citizen petition. It is a position statement from the Pan American Health Organization regarding thalidomide use in leprosy treatment, arguing against thalidomide reintroduction for Erythema nodosum leprosum and advocating for alternative treatments like cl | Other | 2005-05-04 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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